SECURESLEEVE, INFANT

Additional Manufacturer Narrative

CUSTOMER CONFIRMED THE PRODUCT WILL NOT BE RETURNING FOR ANALYSIS. THEREFORE, THIS EVENT IS REPORTED BASED ON THE INFORMATION PROVIDED BY THE CUSTOMER. THROUGH FOLLOW-UP COMMUNICATION, IT WAS DETERMINED THAT THE REPORTED ISSUE WAS RELATED TO THE PRODUCT CROSS-REFERENCE NOT ALIGNING WITH THE APPROPRIATE SIZE REQUIRED BY THE CUSTOMER. THE CROSS-REFERENCE CONCERN STEMS FROM THE CUSTOMER BEING NEW TO THIS PRODUCT. THE DIMENSIONS OF PART 8168I DIFFER FROM THE PRODUCT THEY HAD PREVIOUSLY USED, RESULTING IN THE RECOMMENDED LARGER SECURE SLEEVE PART 8168P NOT MEETING THEIR CLINICAL NEEDS. AS A RESULT, THE CUSTOMER DECIDED TO SWITCH TO A COMPETITOR PRODUCT. A REVIEW OF THE COMPLAINT DATABASE, DID NOT REVEAL ANY ADDITIONAL COMPLAINTS RELATED TO IV ISSUES, THEREFORE THIS IS AN ISOLATED EVENT. INSTRUCTIONS FOR USE (IFU) WERE REVIEWED AND FOUND TO PROVIDE ADEQUATE INSTRUCTIONS AND WARNINGS FOR SAFE AND EFFECTIVE USE OF THE DEVICE. THE IFU STATES DO NOT USE THIS DEVICE WITH SOMEONE WHO HAS CONTINUED HIGHLY AGGRESSIVE OR COMBATIVE BEHAVIOR, SELF-DESTRUCTIVE BEHAVIOR, OR WHO IS DEEMED TO BE AN IMMEDIATE RISK TO THEMSELVES OR OTHERS. AVOID USING ON A PATIENT WITH A DISLOCATION OR FRACTURE ON THE LIMB, OR IF AN IV OR WOUND SITE COULD BE COMPROMISED BY THE DEVICE. ADDITIONAL OR DIFFERENT BODY OR LIMB RESTRAINTS MAY BE NEEDED TO REDUCE THE RISK OF THE PATIENT GETTING ACCESS TO THE LINE, WOUND, OR TUBE SITE. AT THIS TIME THERE IS NO EVIDENCE THAT A MANUFACTURING NON-CONFORMITY CONTRIBUTED TO THE REPORTED COMPLAINT. ALL COMPLAINTS ARE TRENDED AND REVIEWED BY MANAGEMENT ON A MONTHLY BASIS. AS A PART OF THE MONTHLY REVIEW, ANY EXCURSION ABOVE THE CONTROL LIMITS FOR THIS FAILURE MODE WILL BE ASSESSED, DOCUMENTED AND ACTED UPON AS WARRANTED. MANUFACTURER REFERENCE FILE (B)(4).

Description of Event or Problem

CUSTOMER REPORTED COMPLAINT ON PRODUCT 8168I. CUSTOMER STATES THAT THE PRODUCT DOES NOT ADEQUATELY SECURE PATIENTS LIMBS RESULTING IN THE LOSS OF IV LINES. CUSTOMER GOES ON TO SAY THIS POSES A RISK TO DISRUPT SURGICAL SITES IF THE PATIENT IS ABLE TO TOUCH OR GRAB IT. TEAM MEMBERS STATES THAT THE PRODUCT LACKS ANY PROTECTIVE STRUCTURE FOR LINES OR TUBES.